CLIA Annual Laboratory Registry Overview
1. CFR 493.1850 requires that once a year CMS make available to physicians and the general public specific information (including information provided to CMS by the Office of the Inspector General) that is useful in evaluating the performance of laboratories.
a. In January a letter is sent to each CMS Location Office requesting any sanctions taken against laboratory in the pervious calendar year.
b. Letters are also sent to the each Accrediting Organization (AO).
c. Timeframe – the Branch Location Offices and AOs have 60 days to respond and submit actions to CMS Baltimore.
2. Once the information is received from the Branch Locations and the AOs it has to be sorted and put in numerical order within each category. There are 10 regulatory sections.
1. A list of laboratories that have been convicted, under Federal or State laws relating to fraud and abuse, false billing or kickbacks.
2. A list of laboratories that have had their CLIA certificate suspended, limited, or revoked, and the reason for the adverse actions.
3. A list of persons who have been convicted of violating CLIA requirements, as specified in section 353(1) of the PHS Act, together with circumstances of each case and the penalties imposed.
4. A list of laboratories on which alternative sanctions have been imposed, showing--
(i) the effective date off the sanctions; (ii) the reason for imposing them; (iii) any corrective action taken by the laboratory; (iv) if the laboratory has achieved compliance, the verified date
of compliance
5. A list of laboratories whose accreditation has been withdrawn or revoked and the reason for the withdrawal or decision.
6. All appeals and hearing decision.
7. A list of laboratories against which CMS has brought suit under Section 493.1846 and the reason for those actions.
8. A list of laboratories that have been excluded from participation in Medicare or Medicaid and the reasons for exclusion.
9. This Section is for “Corrections of any Erroneous Statements of Information that Appeared in the 2003 Registry”.
10. Other Actions. This Section includes other Specific information that may be useful in evaluating the performance of Laboratories, as specified in 493 CFR 1859(A). It also includes information provided by CLIA exempt status.
The Registry can also include SETTLEMENTS which is generally supplied by the Office of the Inspector General.
3. Once the Branch Locations have finished input for the calendar year under review into the data system (AEM – ASPEN Enforcement Manager), a report is run that collates the information in numerical order and per section (1 through 10). All actions taken by the AOs must be entered into AEM manually.
4. A final Laboratory Registry report is run when all of the information is complete. This report is checked for accuracy by the Branch Locations, AOs, and CMS Baltimore prior to publication on the CLIA website.
2019 CLIA LAB REGISTRY
Laboratory Registry Activity from 01/01/2019 thru 12/31/2019
(AS REQUIRED BY SECTION 353(N) OF THE PUBLIC HEALTH SERVICE ACT)
1. LABORATORIES SUBJECT TO CLIA THAT HAVE BEEN CONVICTED, UNDER FEDERAL OR STATE LAWS RELATING TO FRAUD AND ABUSE, FALSE BILLING, OR KICKBACKS.
*** N O D A T A F O U N D ***
2. LABORATORIES THAT HAVE HAD THEIR CLIA CERTIFICATE SUSPENDED, LIMITED, OR REVOKED, AND THE REASON FOR THE ADVERSE ACTION. (MEDICARE CANCELLATION, A PRINCIPAL SANCTION, HAS BEEN INCLUDED IN THIS CATEGORY.)
CHRISTOPHER GARZA, DIRECTOR
SOUTHWEST KIDNEY INSTITUTE, PLC
2538 E UNIVERSITY DR, STE 110
PHOENIX, AZ 85034
CLIA ID# 03D2114951
SANCTION:
EFFECTIVE DATE:
REASON:
STEPHEN LOCKE, DIRECTOR
FIVE RIVERS MEDICAL CENTER
2801 MEDICAL CENTER DRIVE
POCAHONTAS, AR 72455
CLIA ID# 04D0468144
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
KEVIN ROSENBLATT, DIRECTOR
VYBREM LABS
1311 FORT ST
BARLING, AR 72923
CLIA ID# 04D2132998
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
Limitation of CLIA Certificate
February 10, 2019
Medicare Cancellation/Suspension
Condition Level Non-Compliance
Unsuccessful PT
Limitation of CLIA Certificate
April 15, 2019
Unsuccessful PT
Compliance Achieved
Revocation of CLIA Certificate
February 13, 2019
Revocation of CLIA Certificate
Revocation Pending Hearing
Revocation of CLIA Certificate
ALLAN KURTZ DO, DIRECTOR
ALLAN KURTZ DO / WARNER MEDICAL CENTER
6325 TOPANGA CANYON BLVD STE 501
WOODLAND HILLS, CA 91367
CLIA ID# 05D0860502
SANCTION:
EFFECTIVE DATE:
REASON:
MICHAEL WENSLEY MD, DIRECTOR
MICHAEL KEITH WENSLEY, MD INC
1382 VALENCIA AVE, STE F
TUSTIN, CA 92780
CLIA ID# 05D0957436
SANCTION:
EFFECTIVE DATE:
REASON:
HAROLD SANCHEZ, DIRECTOR
BRIDGEPORT HOSPITAL LABORATORY
267 GRANT ST
BRIDGEPORT, CT 06610
CLIA ID# 07D0099572
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
REASON:
Limitation of CLIACertificate
September 16, 2019
Cancellation of Medicare Approval
Suspension
Condition Level Non-Compliance with IJ
Unsuccessful PT
Limitation of CLIA Certificate
January 10, 2019
Medicare Cancellation/Suspension
Condition Level Non-Compliance
Unsuccessful PT
Limitation of CLIA Certificate
February 11, 2019
Condition Level Non-Compliance with IJ
Suspension And Limitation Lifted
Compliance Achieved
Based on a follow-up survey, the laboratory has been found to be
compliant with the CLIA requirements; therefore, the limitation under
Histopathology has been lifted.
SETH GULLER, PHD, DIRECTOR
GYN / ENDOCRINE LABORATORY
310 CEDAR ST
NEW HAVEN, CT 06510
CLIA ID# 07D1043038 Cancel Medicare/Medicaid Approval SANCTION: Limitation of CLIA Certificate
EFFECTIVE DATE: November 7, 2019
Condition Level Non-Compliance REASON: Improper PT Testing Referral Activities
STATUS: Laboratory voluntarily Ceased Testing
Sanction final due to Intentional Proficiency Testing Referral under the analytes of REASON: TSH and HCG. The laboratory's CLIA certificate has been limited for TSH and HCG. The laboratory voluntary ceased testing under TSH and HCG.
DAVID LAUREN, DIRECTOR AFC URGENT CARE STAMFORD 3000 SUMMER STREET STAMFORD, CT 06905 CLIA ID# 07D2079387
SANCTION: Limitation of CLIA Certificate
EFFECTIVE DATE: November 8, 2019
REASON: Unsuccessful PT
STATUS: Compliance Achieved
REASON: Laboratory has been limited under the analyte of WBC/DIFF
KEITH OBRIEN, DIRECTOR
STATLAB MOBILE
19101 SW 108TH AVE UNIT 4
MIAMI, FL 33157
CLIA ID# 10D2097278
SANCTION: Cancel Medicare/Medicaid Approval Revocation of CLIA Certificate Suspension of CLIA Certificate
EFFECTIVE DATE: November 25, 2019
November 25, 2019
November 25, 2019
REASON: Cancellation of Medicare Approval Revocation
Condition Level Non-Compliance with IJ
Revocation of CLIA Certificate
STATUS: Revocation of CLIA Certificate
GABRIELE TEERMANN, DIRECTOR TETON VALLEY HOSPITAL 120 E HOWARD ST DRIGGS, ID 83422 CLIA ID# 13D0520979
SANCTION: Limitation of CLIA Certificate
EFFECTIVE DATE: April 26, 2019
REASON: Condition Level Non-Compliance Unsuccessful PT
CLARK DAINES, DIRECTOR REXBURG MEDICAL CENTER 393 E 2ND NORTH REXBURG, ID 83440 CLIA ID# 13D0521010
SANCTION: Limitation of CLIA Certificate
EFFECTIVE DATE: November 8, 2019
REASON: Condition Level Non-Compliance Unsuccessful PT
GABRIELE TEERMAN, DIRECTOR NELL J REDFIELD MEMORIAL HOSPITAL 150 N 200 W MALAD CITY, ID 83252 CLIA ID# 13D0705741
SANCTION: Limitation of CLIA Certificate
EFFECTIVE DATE: April 26, 2019
REASON: Condition Level Non-Compliance Unsuccessful PT
ANITA MARTIN, DIRECTOR
ST VINCENT MERCY HOSPITAL 1331 SOUTH A ST
ELWOOD, IN 46036 CLIA ID# 15D0352313
SANCTION: Limitation of CLIA Certificate
EFFECTIVE DATE: September 5, 2019
REASON: Improper PT Testing Referral Activities
ANITA MARTIN, DIRECTOR
MID AMERICA CLIN LAB/ST VINCENT FISHERS HOSP LAB
13861 OLIO RD
FISHERS, IN 46037 CLIA ID# 15D1087222
SANCTION: Limitation of CLIA Certificate
EFFECTIVE DATE: September 5, 2019
REASON: Improper PT Testing Referral Activities
MARILYN MCMILLEN MD, DIRECTOR COMBINED PHYSICIANS LAB
469 WEST PLEASANT STREET CYNTHIANA, KY 41031
CLIA ID# 18D0648560
SANCTION: Limitation of CLIA Certificate
EFFECTIVE DATE: December 19, 2019
Cancellation of Medicare Approval REASON: Suspension
Condition Level Non-Compliance Unsuccessful PT
STATUS: Compliance Achieved
JOSE MONTEIRO, DIRECTOR JOSE A MONTEIRO MD, PC 211 MILLIKEN BLVD
FALL RIVER, MA 02721 CLIA ID# 22D0949481
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
REASON:
RUHANNI SUAN, DIRECTOR DOCTOR'S CLINIC
106 W 12TH
CARUTHERSVILLE, MO 63830 CLIA ID# 26D0442194
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
SHERIE HALL, DIRECTOR
LAKE REGIONAL CLINIC - ELDON 416 S MAPLE STE C
ELDON, MO 65026 CLIA ID# 26D0445864
SANCTION:
EFFECTIVE DATE:
REASON:
Cancel Medicare/Medicaid Approval Revocation of CLIA Certificate
January 23, 2019
January 31, 2019
Failure To Submit Acceptable POC or AOC
Compliance Achieved
Based on a revisit the laboratory is back in compliance.
Limitation of CLIA Certificate
June 10, 2019
Unsuccessful PT
Certificate Reinstated Compliance Achieved
Limitation of CLIA Certificate
April 19, 2019
Unsuccessful PT
JOSEPH LOMBARDO, DIRECTOR
SSM HEALTH ST JOSEPH HOSPITAL LAKE ST LOUIS ATTENTION LABORATORY
LAKE SAINT LOUIS, MO 63367 CLIA ID# 26D0652111
SANCTION: Suspension of CLIA Certificate
EFFECTIVE DATE: February 25, 2019
REASON: Improper PT Testing Referral Activities
Suspension of CLIA Certificate STATUS:
CHARLES PEWITT, DIRECTOR JACKSON MEDICAL CENTER 2387 W JACKSON BLVD JACKSON, MO 63755
CLIA ID# 26D0969305
SANCTION: Cancel Medicare/Medicaid Approval
EFFECTIVE DATE: October 1, 2019
REASON: 2 Year Prohibition From Owning, Operating and Directing Condition Level Non-Compliance with IJ
Revocation of CLIA Certificate
Failure To Submit Acceptable POC or AOC
STATUS: Revocation of CLIA Certificate
ALAK, BAHA and, DIRECTOR ABDUL NAUSHAD MD PC DBA ADVANCED PAIN CENTER 2865 JAMES BLVD POPLAR BLUFF, MO 63901 CLIA ID# 26D1101962
SANCTION: Suspension of CLIA Certificate Revocation of CLIA Certificate
EFFECTIVE DATE: October 25, 2019 December 17, 2019
REASON: Condition Level Non-Compliance with IJ Failure To Submit Acceptable POC or AOC
STATUS: Revocation Pending Hearing Hearing Requested
Appeal Filed By Laboratory
JUSTIN CAMILLO, DIRECTOR
MIDWEST INSTITUTE FOR ADDICTION 711 OLD BALLAS ROAD
SAINT LOUIS, MO 63141 CLIA ID# 26D2117796
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
XIAN, FENG KEIL, DEBORAH and, DIRECTOR QUANTOX LAB
4633 WORLD PARKWAY CIRCLE STE 103 SAINT LOUIS, MO 63143
CLIA ID# 26D2135849
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
ASHLEY HYDER, DIRECTOR WEST
HILLS HEALTHCARE 2163 NW 2ND ST MCMINNVILLE, OR 97128 CLIA ID# 38D0622849
SANCTION:
EFFECTIVE DATE:
REASON:
Cancel Medicare/Medicaid Approval Revocation of CLIA Certificate Suspension of CLIA Certificate
February 16, 2019
April 3, 2019
April 3, 2019
Condition Level Non-Compliance with IJ
Revocation of CLIA Certificate
Suspension of CLIA Certificate
November 9, 2019
Condition Level Non-Compliance with IJ Failure to Correct Deficiencies
Failure To Submit Acceptable POC or AOC
Hearing Requested
Appeal Filed By Laboratory
Limitation of CLIA Certificate
June 25, 2019
Condition Level Non-Compliance Unsuccessful PT
ERIN REILLY, DIRECTOR DOCTORS CARE - RED BANK 1847 S LAKE DRIVE LEXINGTON, SC 29073 CLIA ID# 42D2038406
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
WILLIAM RODNEY, DIRECTOR MEDICOS PARA LA FAMILIA 3040 COVINGTON PIKE, SUITE 100 MEMPHIS, TN 38128 CLIA ID# 44D0964458
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
BRYAN JANSSEN, DIRECTOR EL CAMPO MEMORIAL HOSPITAL 303 SANDY CORNER ROAD EL CAMPO, TX 77437 CLIA ID# 45D0495521
SANCTION:
EFFECTIVE DATE:
REASON:
Limitation of CLIA Certificate
June 25, 2019
Condition Level Non-Compliance Unsuccessful PT
Certificate Reinstated
Compliance Achieved
Cancel Medicare/Medicaid Approval
September 16, 2019
2 Year Prohibition From Owning, Operating and Directing Medicare Cancellation/Suspension
Improper PT Testing Referral Activities Revocation of CLIA Certificate
Revocation of CLIA Certificate
Hearing Decision Sustained CMS Sanc Determ
Limitation of CLIA Certificate
August 22, 2019
Unsuccessful PT
AUSTIN OGWU, DIRECTOR ALPHA MEDICAL CENTER 2505 WEST BELTLINE ROAD LANCASTER, TX 75146 CLIA ID# 45D1010521
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
Revocation of CLIA Certificate
January 3, 2019
Condition Level Non-Compliance with IJ
Revocation of CLIA Certificate
Revocation of CLIA Certificate
3. A LIST OF PERSONS CONVICTED OF VIOLATING CLIA REQUIREMENTS AS SPECIFIED IN SECTION 353(1) OF THE PUBLIC HEALTH SERVICES ACT, WITH THE CIRCUMSTANCES OF EACH CASE AND THE PENALTIES IMPOSED.
*** N O D A T A F O U N D ***
4. A LIST OF LABORATORIES ON WHICH ALTERNATIVE SANCTIONS HAVE BEEN IMPOSED, SHOWING -
(I) THE EFFECTIVE DATE OF THE SANCTIONS (II) THE REASON FOR IMPOSING THEM (III) ANY CORRECTIVE ACTION TAKEN BY THE LABORATORY AND (IV) IF LABORATORY HAS ACHIEVED COMPLIANCE, THE VERIFIED DATE OF THE COMPLIANCE
DARLENE LEE, DIRECTOR
WHITE MOUNTAIN REGIONAL MEDICAL CENTER
118 S MOUNTAIN AVE
SPRINGERVILLE, AZ 85938
CLIA ID# 03D0533657
SANCTION:
EFFECTIVE DATE:
REASON:
CHRISTOPHER GARZA, DIRECTOR
SOUTHWEST KIDNEY INSTITUTE, PLC
2538 E UNIVERSITY DR, STE 110
PHOENIX, AZ 85034
CLIA ID# 03D2114951
SANCTION:
EFFECTIVE DATE:
REASON:
STEPHEN LOCKE, DIRECTOR
FIVE RIVERS MEDICAL CENTER
2801 MEDICAL CENTER DRIVE
POCAHONTAS, AR 72455
CLIA ID# 04D0468144
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
Directed Plan of Correction (DPOC)
January 8, 2019
Condition Level Non-Compliance
Unsuccessful PT
Directed Plan of Correction (DPOC)
Suspension of Part of Medicare/Medicaid
February 8, 2019
February 10, 2019
Medicare Cancellation/Suspension
Condition Level Non-Compliance
Unsuccessful PT
Suspension of Part of Medicare/Medicaid
April 15, 2019
Unsuccessful PT
Compliance Achieved
ALLAN KURTZ DO, DIRECTOR
ALLAN KURTZ DO / WARNER MEDICAL CENTER
6325 TOPANGA CANYON BLVD STE 501
WOODLAND HILLS, CA 91367
CLIA ID# 05D0860502
SANCTION:
EFFECTIVE DATE:
REASON:
MICHAEL WENSLEY MD, DIRECTOR
MICHAEL KEITH WENSLEY, MD INC
1382 VALENCIA AVE, STE F
TUSTIN, CA 92780
CLIA ID# 05D0957436
SANCTION:
EFFECTIVE DATE:
REASON:
SETH GULLER, PHD, DIRECTOR
GYN / ENDOCRINE LABORATORY
310 CEDAR ST
NEW HAVEN, CT 06510
CLIA ID# 07D1043038
SANCTION:
EFFECTIVE DATE:
REASON:
Directed Plan of Correction (DPOC)
Suspension of Part of Medicare/Medicaid
September 14, 2019
September 16, 2019
Cancellation of Medicare Approval
Suspension
Condition Level Non-Compliance with IJ
Unsuccessful PT
Directed Plan of Correction (DPOC) Suspension of
Part of Medicare/Medicaid
January 8, 2019
January 10, 2019
Medicare Cancellation/Suspension
Condition Level Non-Compliance
Unsuccessful PT
Civil Money Penalty
Directed Plan of Correction (DPOC)
November 7, 2019
November 7, 2019
Sanction final due to Intentional Proficiency Testing Referral under the analytes of TSH and HCG. The laboratory's CLIA certificate has been limited for TSH and HCG. The laboratory has voluntarily ceased testing under TSH and HCG.
DAVID LAUREN, DIRECTOR AFC URGENT CARE STAMFORD 3000 SUMMER STREET STAMFORD, CT 06905
CLIA ID# 07D2079387
SANCTION:
EFFECTIVE DATE:
REASON:
BENJAMIN HELGEMO, DIRECTOR HELGEMO AND LIOU PEDIATRICS PA 2040 TAMIAMI TRL STE C PORT CHARLOTTE, FL 33948 CLIA ID# 10D1028020
SANCTION:
EFFECTIVE DATE:
REASON:
KEITH OBRIEN, DIRECTOR STATLAB MOBILE 19101 SW 108TH AVE UNIT 4 MIAMI, FL 33157 CLIA ID# 10D2097278
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
Suspension of All of Medicare/Medicaid
November 8, 2019
Laboratory has been limited under the analyte of WBC DIFF.
Directed Plan of Correction (DPOC)
December 9, 2019
Unsuccessful PT
Directed Plan of Correction (DPOC)
March 30, 2019
Unsuccessful PT
Compliance Achieved
RAMON RAMOS, DIRECTOR RAMON RAMOS, MD 412 US HWY 80 POOLER, GA 31322 CLIA ID# 11D2103325
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
GABRIELE TEERMAN, DIRECTOR
TETON VALLEY HOSPITAL 120 E HOWARD ST DRIGGS, ID 83422 CLIA ID# 13D0520979
SANCTION:
EFFECTIVE DATE:
REASON:
CLARK DAINES, DIRECTOR REXBURG MEDICAL CENTER 393 E 2ND NORTH REXBURG, ID 83440 CLIA ID# 13D0521010
SANCTION:
EFFECTIVE DATE:
REASON:
Directed Plan of Correction (DPOC)
November 30, 2019
Condition Level Non-Compliance
Unsuccessful PT
Laboratory voluntarily Ceased Testing
Directed Plan of Correction (DPOC)
Suspension of Part of Medicare/Medicaid
April 26, 2019
Condition Level Non-Compliance
Unsuccessful PT
Directed Plan of Correction (DPOC)
Suspension of Part of Medicare/Medicaid
November 8, 2019
Condition Level Non-Compliance
Unsuccessful PT
GABRIELE TEERMAN, DIRECTOR NELL J REDFIELD MEMORIAL HOSPITAL 150 N 200 W MALAD CITY, ID 83252 CLIA ID# 13D0705741
SANCTION: Directed Plan of Correction (DPOC)
Suspension of Part of Medicare/Medicaid
EFFECTIVE DATE: April 26, 2019
REASON: Condition Level Non-Compliance
Unsuccessful PT
DANIEL KLINK, DIRECTOR MID AMERICA CLINICAL LABORATORIES ST VINCENT WILLIAMSPORT LAB 412 N MONROE ST WILLIAMSPORT, IN 47993 CLIA ID# 15D0035759
SANCTION:
EFFECTIVE DATE:
REASON:
ANITA MARTIN, DIRECTOR ST VINCENT MERCY HOSPITAL 1331 SOUTH A ST ELWOOD, IN 46036 CLIA ID# 15D0352313
SANCTION:
EFFECTIVE DATE:
REASON:
Civil Money Penalty
September 5, 2019
Improper PT Testing Referral Activities
Civil Money Penalty
Suspension of Part of Medicare/Medicaid
September 5, 2019
Improper PT Testing Referral Activities
ANITA MARTIN, DIRECTOR MID AMERICA CLIN LAB/ST VINCENT FISHERS HOSP LAB 13861 OLIO RD FISHERS, IN 46037 CLIA ID# 15D1087222
SANCTION:
EFFECTIVE DATE:
REASON:
MARILYN MCMILLEN MD, DIRECTOR COMBINED PHYSICIANS LAB 469 WEST PLEASANT STREET CYNTHIANA, KY 41031 CLIA ID# 18D0648560
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
PAUL SPENCER, DIRECTOR AALFA FAMILY PRACTICE, PA 4465 WHITE BEAR PARKWAY SUITE 1 WHITE BEAR LAKE, MN 55110 CLIA ID# 24D0399412
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
Civil Money Penalty
Suspension of Part of Medicare/Medicaid
September 5, 2019
Improper PT Testing Referral Activities
Directed Plan of Correction (DPOC) Suspension of Part of Medicare/Medicaid
April 17, 2019 December 19, 2019
Condition Level Non-Compliance Unsuccessful PT
Compliance Achieved
Civil Money Penalty
February 5, 2019
Improper PT Testing Referral Activities
Compliance Achieved
JOSEPH LOMBARDO, DIRECTOR
SSM HEALTH ST JOSEPH HOSPITAL LAKE ST LOUIS ATTENTION LABORATORY LAKE SAINT LOUIS, MO 63367 CLIA ID# 26D0652111
SANCTION:
EFFECTIVE DATE:
REASON:
CHARLES PEWITT, DIRECTOR JACKSON MEDICAL CENTER 2387 W JACKSON BLVD JACKSON, MO 63755 CLIA ID# 26D0969305
SANCTION:
EFFECTIVE DATE:
REASON:
Civil Money Penalty
February 25, 2019
Improper PT Testing Referral Activities
Civil Money Penalty
Directed Plan of Correction (DPOC)
Suspension of All of Medicare/Medicaid
October 1, 2019
October 1, 2019
October 4, 2019
Condition Level Non-Compliance with IJ
Failure to Correct Deficiencies
ALAK, BAHA and, DIRECTOR ABDUL NAUSHAD MD PC DBA
ADVANCED PAIN CENTER
2865 JAMES BLVD
POPLAR BLUFF, MO 63901
CLIA ID# 26D1101962
SANCTION:
EFFECTIVE DATE:
REASON:
Civil Money Penalty Directed Plan of Correction (DPOC)
October 22, 2019 November 7, 2019
Revocation Pending Hearing Hearing Requested Appeal Filed by Laboratory
JOSEPH LOMBARDO, DIRECTOR SSM IMAGING KOENIG BUILDING 400 MEDICAL PLAZA, SUITE 50 LAKE SAINT LOUIS, MO 63367 CLIA ID# 26D2020571
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
JUTIN CAMILLO, DIRECTOR MIDWEST INSTITUTE FOR ADDICTION
711 OLD BALLAS ROAD SAINT LOUIS, MO 63141 CLIA ID# 26D2117796
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
DAWN KELK, DIRECTOR VALLEY HOSPITAL FERTILITY CENTER, THE 140 EAST RIDGEWOOD AVENUE, SUITE 590S PARAMUS, NJ 07652 CLIA ID# 31D0981068
SANCTION:
EFFECTIVE DATE:
REASON:
Civil Money Penalty Directed Portion Plan of Correction (DPPOC)
February 25, 2019
Improper PT Testing Referral Activities
Compliance Achieved
Civil Money Penalty
February 16, 2019
2 Year Prohibition From Owning, Operating and Directing Condition Level Non-Compliance with IJ Revocation of CLIA Certificate Failure To Submit Acceptable POC or AOC Lab Owner/Oper Prohibited From Owning Lab
Revocation of CLIA Certificate
Civil Money Penalty
July 2, 2019
Improper PT Testing Referral Activities
STATUS: Compliance achieved
SUSAN FUHRMAN, DIRECTOR OHIOHEALTH RIVERSIDE METHODIST HOSPITAL CENTRAL LAB 3535 OLENTANGY RIVER ROAD COLUMBUS, OH 43214 CLIA ID# 36D0329604
SANCTION: Directed Plan of Correction (DPOC) Directed Portion Plan of Correction (DPPOC)
EFFECTIVE DATE: November 7, 2019
REASON: Failure To Submit Acceptable POC or AOC
SYED MOHSIN, DIRECTOR
OHIOHEALTH MARION GENERAL HOSPITAL CORE LAB 1000 MCKINLEY PARK DRIVE MARION, OH 43302 CLIA ID# 36D0330647
SANCTION:
EFFECTIVE DATE:
REASON:
SYED MOHSIN, DIRECTOR OHIOHEALTH MARION MEDICAL CAMPUS LAB 1040 DELAWARE AVENUE MARION, OH 43302 CLIA ID# 36D0330667
SANCTION:
EFFECTIVE DATE:
REASON:
Directed Plan of Correction (DPOC) Directed Portion Plan of Correction (DPPOC)
August 30, 2019 September 15, 2019
Failure To Submit Acceptable POC or AOC
Directed Plan of Correction (DPOC) Directed Portion Plan of Correction (DPPOC)
July 10, 2019
Failure To Submit Acceptable POC or AOC
GREGORY KELLEY DO, DIRECTOR KELLEY FAMILY CLINIC 13190 NE 23RD ST CHOCTAW, OK 73020 CLIA ID# 37D0469542
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
ASHLEY HYDER, DIRECTOR WEST HILLS HEALTHCARE 2163 NW 2ND ST MCMINNVILLE, OR 97128 CLIA ID# 38D0622849
SANCTION:
EFFECTIVE DATE:
REASON:
PAULA ANDERSON, DIRECTOR COLONIAL FAMILY PRACTICE 325 BROAD STREET SUMTER, SC 29150 CLIA ID# 42D0919829
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
Directed Plan of Correction (DPOC)
October 17, 2019
Condition Level Non-Compliance
Compliance Achieved
Directed Plan of Correction (DPOC) Suspension of Part of Medicare/Medicaid
June 25, 2019
Condition Level Non-Compliance Unsuccessful PT
Directed Plan of Correction (DPOC)
June 18, 2019
Condition Level Non-Compliance
Unsuccessful PT
Laboratory voluntarily Ceased Testing
1
ERIN REILLY, DIRECTOR DOCTORS CARE - RED BANK 1847 S LAKE DRIVE LEXINGTON, SC 29073 CLIA ID# 42D2038406
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
WILLIAM RODNEY, DIRECTOR MEDICOS PARA LA FAMILIA 3040 COVINGTON PIKE, SUITE 100 MEMPHIS, TN 38128 CLIA ID# 44D0964458
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
BRYAN JANSSEN, DIRECTOR EL CAMPO MEMORIAL HOSPITAL
303 SANDY CORNER ROAD EL CAMPO, TX 77437
CLIA ID# 45D0495521
SANCTION:
EFFECTIVE DATE:
REASON:
Directed Plan of Correction (DPOC) Cancel Medicare/Medicaid Approval
July 18, 2019
August 9, 2019
Medicare Cacellation/Suspension
Unsuccessful PT
Certificate Reinstated
Compliance Achieved
Cancel Medicare/Medicaid Approval
September 16, 2019
2 Year Prohibition From Owning, Operating and Directing
Medicare Cancellation/Suspension
Improper PT Testing Referral Activities Revocation of CLIA Certificate
Revocation of CLIA Certificate Hearing Decision Sustained CMS Sanc Determ
Suspension of Part of Medicare/Medicaid
August 22, 2019
Unsuccessful PT
CARL EVANS, DIRECTOR
DIMMIT REGIONAL HOSPITAL
704 HOSPITAL DRIVE CARRIZO
SPRINGS, TX 78834
CLIA ID# 45D0506298
SANCTION: Directed Plan of Correction (DPOC)
EFFECTIVE DATE: November 4, 2019
REASON: Condition Level Non-Compliance with IJ
OSAMA NAHAS, DIRECTOR CROSSPOINT MEDICAL CLINIC 2505 W TRENTONTRENT
EDINBURG, TX 78539 CLIA ID# 45D1038599
SANCTION: Directed Plan of Correction (DPOC)
EFFECTIVE DATE: April 10, 2019
REASON: Condition Level Non-Compliance
STATUS: Compliance Achieved
ALBERTO GONZALEZ, DIRECTOR
SOUTH TEXAS CLINICAL LABORATORY LLP 418 SOUTH 6TH STREET
KINGSVILLE, TX 78363 CLIA ID# 45D1075228
SANCTION: Directed Plan of Correction (DPOC)
EFFECTIVE DATE: November 4, 2019
REASON: Condition Level Non-Compliance with IJ
DANIEL MERKI, DIRECTOR
BSA PHYSICIANS GROUP, INC D/B/A BSA FAMILY MEDICAL 3501 SONCY
AMARILLO, TX 79119 CLIA ID# 45D2133585
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
REASON
STEVE HALE, DIRECTOR ESSEX PEDIATRICS
89 MAIN ST
ESSEX JUNCTION, VT 05452 CLIA ID# 47D0091383
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
REASON:
Directed Plan of Correction (DPOC)
July 9, 2019
Condition Level Non-Compliance with IJ
Laboratory voluntarily Ceased Testing
Changed to Certificate Of Waiver
Civil Money Penalty
Directed Plan of Correction (DPOC)
February 21, 2019
May 10, 2019
Improper PT Testing Referral Activities
Compliance Achieved
CMP Imposed
5. LABORATORIES WHOSE ACCREDITATION HAS BEEN WITHDRAWN OR REVOKED AND THE REASON FOR THE WITHDRAWAL OR REVOCATION. (INCLUDES ALL OTHER ADVERSE ACTIONS TAKEN BY THE ACCREDITATION ORGANIZATIONS)
ALAN BARKSDALE, DIRECTOR
REGIONAL CARE PARTNERS - MAIN CLINICAL LABORATORY (Shoals Hospital-Main Clinical Laboratory) 201 W AVALON AVE
MUSCLE SHOALS, AL 35661 CLIA ID# 01D0302683 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
GARY MCCULLOCH, DIRECTOR
ECLECTIC FAMILY CARE LLC
575 CLAUD ROAD SUITE 1000 ECLECTIC, AL 36024 CLIA ID# 01D0905035 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
RYAN SWAPP, DIRECTOR YUMA REGIONAL MEDICAL CENTER 2400 SOUTH AVENUE A
YUMA, AZ 85364
CLIA ID# 03D0531581 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
Probation
March 13, 2019
Quality and Severity of Deficiencies Is Significant Enough to Question Ability to Sustain Corrections; Corrective Action Fails to Support Implementation and Prevention of Recurrence in One or More Areas of the Laboratory
As of 02/07/2020 Probation Still in Effect
Cease Testing for Hematocrit, Hemoglobin, Platelet Count, Red Blood Cell Count (Erythrocyte Count) (RBC), White Blood Cell Count (Leukocyte Count) (WBC), White Blood Cell Differential (WBC Diff)
July 15, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect
Probation
June 26, 2019
Quality and Severity of Deficiencies Is Significant Enough to Question Ability to Sustain Corrections; Corrective Action Fails to Support Implementation and Prevention of Recurrence in One or More Areas of the Laboratory
As of 02/07/2020 Probation Still in Effect
ROEL GALLO, DIRECTOR YAVAPAI REGIONAL MEDICAL CENTER
1003 WILLOW CREEK RD
PRESCOTT, AZ 86301
CLIA ID# 03D0534045 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
KEITH AGRE, DIRECTOR KEITH AGRE MD MED
CORP 1125 S BEVERLY DR, STE 110 LOS ANGELES, CA 90035
CLIA ID# 05D0546307 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
NOGBA PAWOO, DIRECTOR MONTCLAIR
HOSPITAL MEDICAL CENTER
5000 SAN BERNADINO ST
MONTCLAIR, CA 91763 CLIA ID# 05D0563949 (TJC)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
Cease Testing for Parasitology
July 31, 2019
Unsuccessful PT
Allowed to Resume Testing on 12/31/2019
Cease Testing for Cholesterol, Glucose, Protein, Total
March 25, 2019
Unsuccessful PT
Test was reinstated on 10/11/2019
Cease Testing for Compatibility Testing
May 10, 2019
Unsuccessful PT
Reinstated effective 11/11/2019
FRED FAUVRE, DIRECTOR FRED M FAUVRE MD 1320 MARICOPA HWY 1 SUTE I
OJAI, CA 93023
CLIA ID# 05D0583533 (COLA)
SANCTION: Cease Testing for Rheumatoid Factor
EFFECTIVE DATE: May 1, 2019
REASON: Unsuccessful PT
STATUS: On 5/6/2019 the lab removed the tests from their Test Menu
TAHIR YAQUB, DIRECTOR ATWATER MEDICAL GROUP 1775 THIRD STREET ATWATER, CA 95301
CLIA ID# 05D0609812 (COLA)
SANCTION: Cease Testing for Cholesterol Cease Testing for Triglycerides
EFFECTIVE DATE: March 25, 2019
November 5, 2019
REASON: Unsuccessful PT
STATUS: Cholesterol Test was reinstated on 11/5/2019 As of 12/31/2019 Cease Testing Still in Effect for Triglycerides
DONGXIANG BU, DIRECTOR SW MEDICAL LABORATORY, INC DBA UNIVERSALDX
3188 AIRWAY AVE STE K2 COSTA MESA, CA 92626 CLIA ID# 05D0676164 (CAP)
SANCTION: Revocation of Accreditation
EFFECTIVE DATE: November 6, 2019
REASON: Laboratory Performance Does Not meet CAP Standards for Accreditation
STATUS: As of 02/07/2020 Not Accredited by CAP
TED LAI, DIRECTOR TED Y LAI MD
210 NORTH GARFIELD AVENUE #303
MONTEREY PARK, CA 91754 CLIA ID# 05D0864587 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
CHRISTOPHER PERKINS, DIRECTOR
Denial of Accreditation
November 27, 2019
Failure to Adhere to COLA – Imposed Required Improvements
No Longer Accredited by COLA
COMMUNITY FOUNDATION MEDICAL GROUP (California Oncology of the Central Valley) 6121 NORTH THESTA AVENUE, #204 FRESNO, CA 93710 CLIA ID# 05D0981677 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
JOSHUA BERGER, DIRECTOR
Cease Testing for Chloride
November 5, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect
COMPREHENSIVE HEALTH FOR ALL FERTILITY MED GRP INC (CHA Fertility Center-Laboratory) 5455 WILSHIRE BLVD STE 1904 LOS ANGELES, CA 90036 CLIA ID# 05D0991770 (CAP)
SANCTION: Probation
EFFECTIVE DATE: September 11, 2019
REASON: Quality and Severity of Deficiencies Is Significant Enough to Question Ability to Sustain Corrections; Corrective Action Fails to Support Implementation and Prevention of Recurrence in One or More Areas of the Laboratory
STATUS: As of 02/07/2020 Probation Still in Effect
JOHN STEWART, DIRECTOR GENWAY CLINICAL LABORATORY (GenWay Biotech Inc-Genway) 7700 RONSON RD
SAN DIEGO, CA 92111 CLIA ID# 05D1100497 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
NOGBA PAWOO, DIRECTOR VICTOR VALLEY GLOBAL MEDICAL CENTER 15248 ELEVENTH ST VICTORVILLE, CA 92395 CLIA ID# 05D2054158 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
JEBEEN FATIMA, MD, DIRECTOR
Denial of Accreditation
December 18, 2019
Laboratory Performance Does Not Meet CAP Standards for Accreditation
As of 02/07/2020 Not Accredited by CAP
Probation
January 9, 2019
Quality and Severity of Deficiencies Is Significant Enough to Question Ability to Sustain Corrections; Corrective Action Fails to Support Implementation and Prevention of Recurrence in One or More Areas of the Laboratory
Removed from Probation on 06/26/2019
DR FATIMA LABORATORY (Fatima & Bahadori Laboratory) 4955 VAN NUYS BLVD STE 415 SHERMAN OAKS, CA 91403 CLIA ID# 05D2088694 (COLA)
SANCTION: Denial of Accreditation
EFFECTIVE DATE: February 21, 2019
REASON: Failure to Adhere to COLA – Imposed Required Improvements
STATUS: No Longer Accredited by COLA
JULIE TAGUCHI, DIRECTOR ARRAYIT CORPORATION 927 THOMPSON PL
SUNNYVALE, CA 94085 CLIA ID# 05D2147467 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
JOSEPH MIGLIOZZI, DIRECTOR REGIONAL GENERAL HOSPITAL WILLISTON
125 SW 7TH ST
WILLISTON, FL 32696 CLIA ID# 10D0272938 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
MARK JUTRAS, DIRECTOR
ADVANCED REPRODUCTIVE CONCEPTS PLLC
1918 RANDOLPH ROAD, SUITE 210 CHARLOTTE, NC 28207 CLIA ID# 10D0681845 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
Probation
December 11, 2019
Quality and Severity of Deficiencies Is Significant Enough to Question Ability to Sustain Corrections; Corrective Action Fails to Support Implementation and Prevention of Recurrence in One or More Areas of the Laboratory
As of 12/31/2019 Probation Still in Effect Denied Accreditation on 01/09/2020
Cease Testing for PO2
July 29, 2019
Unsuccessful PT
No Longer Accredited by COLA
Revocation of Accreditation
February 13, 2019
Laboratory Performance Does Not Meet CAP Standards for Accreditation
As of 12/31/2019 Not Accredited by CAP
KAREN BOOKBINDER, DIRECTOR EVE OF KENDALL INC 8603 S DIXIE HWY STE 102
MIAMI, FL 33143 CLIA ID# 10D0897202 (COLA)
SANCTION: Cease Testing for D(Rho) Type
EFFECTIVE DATE: October 7, 2019
REASON: Unsuccessful PT
STATUS: As of 12/31/2019 Cease Testing Still in Effect
ELIZABETH REILLY HAYS, DIRECTOR MARIANO D CIBRAN MD CORP D/B/A ST PETERSBURG PEDIATRIC (East Bay) 3475 EAST BAY DR LARGO, FL 33771 CLIA ID# 10D0954831 (COLA)
SANCTION: Cease Testing for White Blood Cell Differential (WBC Diff)
EFFECTIVE DATE: May 1, 2019
REASON: Unsuccessful PT
STATUS: As of 12/31/2019 Cease Testing Still in Effect
ABDUL SOFI, DIRECTOR
PREMIER MEDICAL CLINIC INC
315 EAST ASH STREET
PERRY, FL 32347
CLIA ID# 10D0958590 (COLA)
SANCTION: Cease Testing for Cholesterol
EFFECTIVE DATE: November 5, 2019
REASON: Unsuccessful PT
STATUS: As of 12/31/2019 Cease Testing Still in Effect
FERNANDO MALAMUD, DIRECTOR FERNANDO C MALAMUD MD PA (Panhandle Cancer Center) 2202 STATE AVE STE 111 PANAMA CITY, FL 32405 CLIA ID# 10D0983766 (COLA)
SANCTION: Cease Testing for Hematocrit, Red Blood Cell Count (Erythrocyte Count) (RBC)
EFFECTIVE DATE: July 29, 2019
REASON: Unsuccessful PT
STATUS: No Longer Accredited by COLA
HILARIO ISABA, DIRECTOR CRONOS CLINICAL LABORATORY
2650 NW 97 AVENUE
MIAMI, FL 33172
CLIA ID#10D1028284 (COLA)
SANCTION: Cease Testing for Creatine Kinase (CK)
EFFECTIVE DATE: July 15, 2019
REASON: Unsuccessful PT
STATUS: On 7/25/2019 the lab removed the tests from their Test Menu
HILARIO ISABA, DIRECTOR FIRST QUALITY LABORATORY
11460 INTER CHANGE CIRCLE NORTH
MIRIMAR, FL 33025
CLIA ID# 10D1056759 (COLA)
SANCTION: Cease Testing for Immunoglobulins IgA
EFFECTIVE DATE: May 21, 2019
REASON: Unsuccessful PT
STATUS: As of 12/31/2019 Cease Testing Still in Effect
AJAZ AFZAL, DIRECTOR ACUTE PATIENT CARE LABORATORY
1032 MANN ST
KISSIMMEE, FL 34741 CLIA ID# 10D2003636 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
HASSAN ALKHATIB, DIRECTOR APEX CLINICAL LABORATORIES INC
933 BEVILLE RD STE 101-G
SOUTH DAYTONA, FL 32119 CLIA ID# 10D2039361 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
ALAN TANNENBAUM, DIRECTOR
Cease Testing for Platelet Count
September 20, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect
Cease Testing for Chloride, Sodium
March 25, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect
CLINICAL LAB SOLUTIONS LLC D/B/A MYTEST DIAGNOSTIC
9671 GLADIOLUS DR STE 102
FORT MYERS, FL 33908
CLIA ID# 10D2116250 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
Cease Testing for Bilirubin, Total
July 29, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect
JUDY LIMBAUGH, DIRECTOR PERDIDO BAY ER (West Florida Hospital-Perdido Bay ER Lab) 9400 W HIGHWAY 98
PENSACOLA, FL 32507
CLIA ID# 10D2140835 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
CHRISTOPHER CAMPO, DIRECTOR SOUTHERN REGIONAL MEDICAL CENTER
11 UPPER RIVERDALE RD SW
RIVERDALE, GA 30274 CLIA ID# 11D0021026 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
ANTHONY MOSER, DIRECTOR PHOEBE WORTH MEDICAL CENTER
807 SOUTH ISABELLA STREET
SYLVESTER, GA 31791 CLIA ID# 11D0266246 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
Cease Testing for Thyroxine, Free
July 19, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect Allowed to Resume Testing on 02/07/2020
Revocation of Accreditation
February 25, 2019
Laboratory Performance Does Not Meet CAP Standards for Accreditation
As of 12/31/2019 Not Accredited by CAP
Probation
May 22, 2019
Quality and Severity of Deficiencies Is Significant Enough to Question Ability to Sustain Corrections; Corrective Action Fails to Support Implementation and Prevention of Recurrence in One or More Areas of the Laboratory
As of 02/07/2020 Probation Still in Effect
HARRY LATHAM, DIRECTOR CRISP REGIONAL HOSPITAL
902 SEVENTH STREET NORTH
CORDELE, GA 31015 CLIA ID# 11D0646027 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
ROBERT COLLINS, DIRECTOR COLLINS CARDIOLOGY 1208 OCILLA ROAD
DOUGLAS, GA 31533 CLIA ID# 11D0988416 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
ROBERT REUTER DO, DIRECTOR CRAWFORD MEMORIAL HOSPITAL 1000 N ALLEN ST
ROBINSON, IL 62454 CLIA ID# 14D0044790 (AAHHS-HFAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
Probation
March 27, 2019; November 1, 2019
Quality and Severity of Deficiencies Is Significant Enough to Question Ability to Sustain Corrections; Corrective Action Fails to Support Implementation and Prevention of Recurrence in One or More Areas of the Laboratory; Laboratory Performance does not meet CAP Standards for Accreditation.
Revoked Accreditation on 11/1/2019 As of 02/07/2020 Not Accredited by CAP
Cease Testing for Thyroxine, Free (FT4)
August 21, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect
Cease Testing for pCO2
February 7, 2019
Unsuccessful PT
As of 12/11/2019 Cease Testing was no longer in effect
DAVID ADE, DIRECTOR DRS ADE & CASTRO 550 30TH AVE #12
MOLINE, IL 61265 CLIA ID# 14D0667413 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
R SCOTT SPRINGER, DIRECTOR CENTER FOR REPRODUCTIVE HEALTH SC
2246 WEBER
CREST HILL, IL 60435 CLIA ID# 14D0992001 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
JIM LU M D, DIRECTOR GOPATH LABORATORIES LLC
1351 BARCLAY CLVD
BUFFALO GROVE, IL 60089 CLIA ID# 14D2037930 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
Cease Testing for Chloride
November 5, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect
Probation
November 13, 2019
Quality and Severity of Deficiencies Is Significant Enough to Question Ability to Sustain Corrections; Corrective Action Fails to Support Implementation and Prevention of Recurrence in One or More Areas of the Laboratory
As of 02/07/2020 Probation is Still in Effect
Probation
January 9, 2019
Quality and Severity of Deficiencies Is Significant Enough to Question Ability to Sustain Corrections; Corrective Action Fails to Support Implementation and Prevention of Recurrence in One or More Areas of the Laboratory
Removed from Probation on 06/26/2019
SHAN REHMAN, DIRECTOR ABC LABS LLC 6449 S PULASKI RD, STE 106
CHICAGO, IL 60629 CLIA ID# 14D2118590 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
JENNIFER BISHOP, DIRECTOR AMERICAN MEDICAL LAB, L T D 10604 SOUTHWEST HWY-1ST FLOOR LAB
CHICAGO RIDGE, IL 60415 CLIA ID# 14D2145997 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
BRET HUBER, DIRECTOR DPLM AT IU HEALTH MORGAN HOSPITAL
2209 JOHN R WOODEN DR
MARTINSVILLE, IN 46151 CLIA ID# 15D0034408 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
Denial of Accreditation
January 24, 2019
Failure to Adhere to COLA – Imposed Required Improvements
No Longer Accredited by COLA
Cease Testing for Hematocrit, Hemoglobin, Platelet Count, Red Blood Cell Count (Erythrocyte Count) (RBC), White Blood Cell Count (Leukocyte Count) (WBC), White Blood Cell Differential (WBC Diff)
November 26, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect
Cease Testing for Compatibility Testing
October 25, 2019
Unsuccessful PT
Cease Testing still in effect on 12/31/2019 Allowed to Resume Testing on 01/07/2020
THOMAS SOZIO, DIRECTOR INDIGOBRIDGE LABORATORIES, LLC
1281 WIN HENTSCHEL BLVD, STE 1231
WEST LAFAYETTE, IN 47906 CLIA ID# 15D2129713 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
KELSEY BENEKE, DIRECTOR AVERA MEDICAL GROUP SPENCER 116 EAST 11TH STREET, SUITE 101
SPENCER, IA 51301
CLIA ID# 16D0385496 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
MICHAEL CAROUGHAN MD, DIRECTOR
ATCHISON HOSPITAL LABORATORY 800 RAVEN HILL DRIVE
ATCHISON, KS 66002 CLIA ID# 17D0448073 (AAHHS-HFAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
Denial of Accreditation
November 6, 2019
Laboratory Performance Does Not Meet CAP Standards for Accreditation
As of 12/31/2020 Not Accredited by CAP
Cease Testing for Aspartate Aminotransferase (AST) (SGOT)
November 5, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect
Cease Testing for Iron, Total
October 25, 2019
Unsuccessful PT
As of 10/28/19 Cease Testing Still in Effect As of 12/31/19, Testing was not resumed
TIM LONG, DIRECTOR TIM LONG MD PSC 1320 ANDREA STREET
BOWLING GREEN, KY 42104 CLIA ID# 18D1000308 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
SHAUN LAWICKI, DIRECTOR OUR LADY OF THE ANGELS HOSPITAL
Cease Testing for Chloride
November 5, 2019
Unsuccessful PT
On 11/12/2019 the lab removed the tests from their Test Menu
433 PLAZA STREET,1ST FLOOR, MAIN BUILDING
BOGALUSA, LA 70427 CLIA ID# 19D0695517 (CAP)
SANCTION: Probation
EFFECTIVE DATE: June 26, 2019
REASON: Quality and Severity of Deficiencies Is Significant Enough to Question Ability to Sustain Corrections; Corrective Action Fails to Support Implementation and Prevention of Recurrence in One or More Areas of the Laboratory
STATUS: As of 02/07/2020 Probation is Still in Effect
OM GARG, DIRECTOR ST CATHERINE LTAC (Prestige Rehab ABG Lab) 14500 HAYNE BOULEVARD 1FIRST FLOOR ABG LAB
NEW ORLEANS, LA 70128 CLIA ID# 19D2071845 (COLA)
SANCTION: Cease Testing for Sodium
EFFECTIVE DATE: August 21, 2019
REASON: Unsuccessful PT
STATUS: No Longer Accredited by COLA
KENT LEWANDROWSKI, DIRECTOR MASSACHUSETTS EYE & EAR 243 CHARLES ST
BOSTON, MA 02114 CLIA ID# 22D0074893 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
PRITI PATEL, DIRECTOR INTERNAL MEDICINE & PREVENTIVE CARE PC 233 WINTHROP STREET TAUNTON, MA 02780 CLIA ID# 22D1030094 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
KEVIN BECKMAN, DIRECTOR ASCENSION BORGESS HOSPITAL 1521 GULL ROAD
KALAMAZOO, MI 49048 CLIA ID# 23D0376741 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
Probation
September 25, 2019
Quality and Severity of Deficiencies Is Significant Enough to Question Ability to Sustain Corrections; Corrective Action Fails to Support Implementation and Prevention of Recurrence in One or More Areas of the Laboratory
As of 02/07/2020 Probation is Still in Effect
Cease Testing for Creatinine
October 10, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect
Cease Testing for T3 Uptake/ Related Tests
August 27, 2019
Unsuccessful PT
Allowed to Resume Testing on 09/19/2019
DIANNE TRUDELL, DIRECTOR CONSULTANTS IN ARTHRITIS & ALLIED COND
G-5085 WEST BRISTOL ROAD
FLINT, MI 48507
CLIA ID# 23D0704875 (COLA)
O
SANCTION: Cease Testing for Hematocrit, Hemoglobin, Platelet Count, Red Blood Cell Count (Erythrocyte Count) (RBC), White Blood Cell Count (Leukocyte Count)
(WBC), White Blood Cell Differential (WBC Diff)
EFFECTIVE DATE: July 29, 2019
REASON: Unsuccessful PT
STATUS: As of 12/31/2019 Cease Testing Still in Effect
BRUCE SALVAGGIO, DIRECTOR MEDICAL PLAZA INTERNAL MEDICINE LAB 10787 NALL AVE
OVERLAND PARK, KS 66211 CLIA ID# 26D0443654 (COLA)
SANCTION: Cease Testing for Creatine Kinase (CK)
EFFECTIVE DATE: August 21, 2019
REASON: Unsuccessful PT
STATUS: No Longer Accredited by COLA
DOUGLAS GLIEDT, DIRECTOR MISSOURI CENTER FOR REPRODUCTIVE MEDICINE (ART Laboratory) 17300 N OUTER FORTY, SUITE 101
CHESTERFIELD, MO 63005 CLIA ID# 26D2078769 (CAP)
SANCTION: Denial of Accreditation
EFFECTIVE DATE: January 21, 2019
REASON: Laboratory Performance Does Not Meet CAP Standards for Accreditation
STATUS: As of 12/31/2019 Not Accredited by CAP
JENNIFER LAPOINTE, DIRECTOR BLACKFEET COMMUNITY HOSPITAL LAB
760 HOSPITAL CIRCLE
BROWNING, MT 59417 CLIA ID# 27D0410108 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
MILTON ZADINA, DIRECTOR COLUMBUS FAMILY PRACTICE ASSOCIATES PC 4214 - 38TH STREET COLUMBUS, NE 68601 CLIA ID# 28D0679911 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
LEONID LI, DIRECTOR SAINT CLARES HOSPITAL LAB, DOVER
SAINT CLARE'S HEALTH SYSTEM 25 POCONO ROAD DENVILLE, NJ 07834 CLIA ID# 31D0005048 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
Cease Testing for Phenobarbital
May 1, 2019
Unsuccessful PT
On 5/7/2019 the lab removed the tests from their Test Menu
Cease Testing for White Blood Cell Differential (WBC Diff)
January 21, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect
Probation
November 4, 2019
Quality and Severity of Deficiencies Is Significant Enough to Question Ability to Sustain Corrections; Corrective Action Fails to Support Implementation and Prevention of Recurrence in One or More Areas of the Laboratory
As of 02/07/2020 Probation is Still in Effect
LEONID LI, DIRECTOR SAINT CLARES HOSPITAL - DENVILLE
SAINT CLARE'S HEALTH SYSTEM
25 POCONO ROAD DENVILLE, NJ 07834 CLIA ID# 31D0115471 (CAP)
SANCTION: Probation
EFFECTIVE DATE: November 4, 2019
REASON: Quality and Severity of Deficiencies Is Significant Enough to Question Ability to Sustain Corrections; Corrective Action Fails to Support Implementation and Prevention of Recurrence in One or More Areas of the Laboratory
STATUS: As of 02/07/2019 Probation Still in Effect
BRIAN FERTIG, DIRECTOR DIABETES AND OSTEOPOROSIS CENTER PC
20 WILLS WAY PISCATAWAY, NJ 08854 CLIA ID# 31D0923476 (COLA)
SANCTION: Cease Testing for Chloride
EFFECTIVE DATE: November 26, 2019
REASON: Unsuccessful PT
STATUS: As of 12/31/2019 Cease Testing Still in Effect
BONNIE CARMICHAEL, DIRECTOR ALTA VISTA REGIONAL HOSPITAL (San Miguel Hospital Corporation) 104 LEGION DRIVE
LAS VEGAS, NM 87701 CLIA ID# 32D0672876 (TJC)
SANCTION: Cease Testing for Compatibility Testing
EFFECTIVE DATE: October 21, 2019
REASON: Unsuccessful PT
STATUS: As of 12/31/2019 Cease Testing still in effect
POURRAT MONAHEMI, DIRECTOR POURRAT MONAHEMI MD (Throgs Neck Medical) 3795 E TREMONT AVENUE
BRONX, NY 10465 CLIA ID# 33D0136757 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
PETER RUMORE, DIRECTOR
Cease Testing for White Blood Cell Differential (WBC Diff)
June 3, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect
RHEUMATOLOGY ASSOCIATES OF LONG ISLAND
7 MEDICAL DRIVE
PORT JEFFERSON STATION, NY 11776 CLIA ID# 33D0158700 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
RICHARD GOLD, DIRECTOR SMITHTOWN MEDICAL SPECIALISTS PC
215 EAST MAIN STREET SMITHTOWN, NY 11787 CLIA ID# 33D0663082 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
Cease Testing for Urea (BUN)
November 5, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect
Cease Testing for Chloride
March 25, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect
HUMAYUN ISLAM, DIRECTOR WESTCHESTER MEDICAL CENTER PATHOLOGY DEPARTMENT (Grasslands Reservation) 100 WOODS ROAD VALHALLA, NY 10595 CLIA ID# 33D0721132 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
ARNOLD WEG, DIRECTOR ARNOLD WEG MD 710 PARK AVENUE, SUITE 1C
NEW YORK, NY 10021 CLIA ID# 33D0887555 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
GRAIG STRAUS, DIRECTOR
Probation
December 11, 2019
Quality and Severity of Deficiencies Is Significant Enough to Question Ability to Sustain Corrections; Corrective Action Fails to Support Implementation and Prevention of Recurrence in One or More Areas of the Laboratory
As of 02/07/2020 Probation is Still in Effect
Cease Testing for Urea (BUN), Sodium, Chloride
October 10, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect
ROCKLAND URGENT CARE FAMILY HEALTH NP, PC 89 SOUTH ROUTE 9W
WEST HAVERSTRAW, NY 10993 CLIA ID# 33D2093011 (COLA)
SANCTION: Cease Testing for Hemoglobin
EFFECTIVE DATE: August 21, 2019
REASON: Unsuccessful PT
STATUS: On 8/28/2019 the lab removed the tests from their Test Menu.
WILLIAM BALLANCE JR, DIRECTOR VIDANT DUPLIN HOSPITAL (Duplin General Hospital) 401 N MAIN STREET KENANSVILLE, NC 28349 CLIA ID# 34D0245237 (TJC)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
JAMES PRIDGEN, DIRECTOR
NORTH WHITEVILLE URGENT CARE
& FAMILY PRACTICE, PA 614 NORTH J K POWELL BLVD WHITEVILLE, NC 28472 CLIA ID# 34D0993008 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
SAID ELFAYAR, DIRECTOR ACCURATE MEDICAL LAB 140 PARKER ROAD W - SUITE A
DANVILLE, VA 24540
CLIA ID# 34D1106621 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
Cease Testing of pO2
July 15, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing still in effect Reinstated effective 1/15/2020
Cease Testing for White Blood Cell Differential (WBC Diff); Cease testing for Hematocrit, hemoglobin, Platelet Count, Red Blood Cell Count (Erythrocyte Count)(RBC), White Blood Cell Count (Leukocyte Count)(WBC), White Blood Cell Differential (WBC Diff); Denial of Accreditation
March 27, 2019; July 1, 2019; October 23, 2019
Unsuccessful PT; Failure to Adhere to COLA-Imposed Required Improvements
No longer Accredited by COLA
Denial of Accreditation
January 24, 2019
Failure to Adhere to COLA – Imposed Required Improvements; Failure to permit a COLA on site survey
No Longer Accredited by COLA
PING WEN, DIRECTOR OHIOHEALTH MARION MEDICAL CAMPUS LAB 1040 DELAWARE AVENUE MARION, OH 43302 CLIA ID# 36D0330667 (CAP)
SANCTION: Probation
EFFECTIVE DATE: April 24, 2019
REASON: Quality and Severity of Deficiencies Is Significant Enough to Question Ability to Sustain Corrections; Corrective Action Fails to Support Implementation and Prevention of Recurrence in One or More Areas of the Laboratory
STATUS: Removed from Probation on 10/23/2019
MARTIN SCHEAR, DIRECTOR SCHEAR FAMILY PRACTICE
1100 SALEM AVENUE
DAYTON, OH 45406 CLIA ID# 36D0349247 (COLA)
SANCTION: Cease Testing for Chloride
EFFECTIVE DATE: July 29, 2019
REASON: Unsuccessful PT
STATUS: On 7/30/2019 the lab removed the tests from their Test Menu
RICHARD BRADSTREET, DIRECTOR GUTHRIE TOWANDA MEMORIAL HOSPITAL LAB (GMG Lab at Towanda) 91 HOSPITAL DRIVE
TOWANDA, PA 18848
CLIA ID# 39D0193491 (TJC)
SANCTION: Cease Testing Creatine Kinase Isoenzyme February
EFFECTIVE DATE: 21, 2019
REASON: Unsuccessful PT
STATUS: Lab discontinued testing CKI effective 2/21/2019
BRIAN LECHER, DIRECTOR FASTER CARE (Inc) 3440 DECLARATION BLVD
SUMTER, SC 29154 CLIA ID# 42D1037699 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
CH JAMESON III, DIRECTOR
Cease Testing for Activated Partial Prothrombin Time
December 12, 2019
Non-Compliance Due to Lack of Proficiency Testing Enrollment
As of 12/31/2019 Cease Testing Still in Effect
MAURY REGIONAL MEDICAL GROUP (MRMG) ONCOLOGY
808 S JAMES CAMPBELL BLVD
COLUMBIA, TN 38401 CLIA ID# 44D0315843 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
ADAM SEEGMILLER, DIRECTOR VANDERBILT UNIVERSITY MEDICAL CENTER
Cease Testing for White Blood Cell Differential (WBC Diff)
June 3, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect
DBA DIAGNOSTIC LABORATORIES-CLINICAL PATHOLOGY
1301 MEDICAL CENTER DR-4605 TVC NASHVILLE, TN 37232 CLIA ID# 44D0659066 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
Probation
December 11, 2019
Quality and Severity of Deficiencies Is Significant Enough to Question Ability to Sustain Corrections; Corrective Action Fails to Support Implementation and Prevention of Recurrence in One or More Areas of the Laboratory
As of 02/07/2020 Probation Still in Effect
JUSTIN ADLER, DIRECTOR SAINT FRANCIS HOSPITAL BARTLETT
2986 KATE BOND ROAD BARTLETT, TN 38133 CLIA ID# 44D1025716 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
PAUL ALLISON, DIRECTOR MEDICAL CLINIC OF HOUSTON/LABORATORY 1701 SUNSET BOULEVARD
HOUSTON, TX 77005 CLIA ID# 45D0489693 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
PATRICK OGIDAN, DIRECTOR GENESIS MEDICAL GROUP
8845 SIX PINES DRIVE, STE 200
SHENANDOAH, TX 77380 CLIA ID# 45D0494205 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
Cease Testing for Compatibility Testing
October 25, 2019
Unsuccessful PT
As of 02/07/2020 Cease Testing Still in Effect
Cease Testing for Anti-HIV
February 5, 2019
Unsuccessful PT
Allowed to Resume Testing on 07/17/2019
Cease Testing for Carbamazepine and Digoxin
July 29, 2019
Unsuccessful PT
On 09/04/2019 the lab removed these tests from their Test Menu
JAVIER SAENZ, DIRECTOR SAENZ MEDICAL CENTER
1000 E EXPRESSWAY 83 SUITE 4 LA JOYA, TX 78560
CLIA ID# 45D0503770 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
DANIEL SCHNEIDER, DIRECTOR NORTHWEST TEXAS HEALTHCARE SYSTEM LABORATORY 1501 SOUTH COULTER ROAD AMARILLO, TX 79106 CLIA ID# 45D0506849 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
JAMES HUMPHREYS MD, DIRECTOR
Cease Testing for Bacteriology
August 21, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect
Cease Testing for Rubella
January 10, 2019
Unsuccessful PT
As of 02/07/2019 Cease Testing Still in Effect
METHODIST HEALTHCARE SYSTEM OF SAN ANTONIO LTD LLP DBA METHODIST HOSPITAL SOUTH 1905 HIGHWAY 97 EAST JOURDANTON, TX 78026 CLIA ID# 45D0685615 (TJC)
SANCTION: Cease Testing of PT and PTT
EFFECTIVE DATE: January 18, 2019
REASON: Unsuccessful PT
STATUS: Reinstated effective 10/25/2019
MARIO SANCHEZ, DIRECTOR NEIGHBORHOOD DOCTOR,THE
106 N MAIN PO BOX 38
LA FERIA, TX 78559 CLIA ID# 45D0706542 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
AURORA MCKINNEY, DIRECTOR MD FAMILY CLINIC - BRUTON
9709 BRUTON ROAD DALLAS, TX 75217
CLIA ID# 45D0935981 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
RAJEEV NARAYAN, DIRECTOR SAN ANTONIO KIDNEY DISEASE CENTER PHYSICIANS GROUP PLLC 2391 NE LOOP 410 SUITE 405 SAN ANTONIO, TX 78217 CLIA ID# 45D0978193 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
Cease Testing for Chloride
March 25, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect
Cease Testing for Thyroid Stimulating Hormone (TSH)
March 25, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect
Cease Testing for Uric Acid March
25, 2019
Unsuccessful PT
Test was reinstated on 10/4/2019
JOSEPH GOIN, DIRECTOR CALVARY MEDICAL CLINIC 8484 WILL CLAYTON PKWY
HUMBLE, TX 77339 CLIA ID# 45D0980081 (COLA)
SANCTION: Cease Testing for White Blood Cell Count (Leukocyte Count)(WBC) June
EFFECTIVE DATE: 3, 2019
REASON: Unsuccessful PT
STATUS: No Longer Accredited by COLA
VINCENT HONRUBIA, DIRECTOR VINCENT F HONRUBIA MD PA 2821 MICHAELANGELO SUITE 201 EDINBURG, TX 78539
CLIA ID# 45D1009691 (COLA)
SANCTION: Cease Testing for Immunoglobulins IgE
EFFECTIVE DATE: February 11, 2019
Unsuccessful PT REASON:
STATUS: No Longer Accredited by COLA
JHONNY BAZAN, DIRECTOR SAN MARTIN DE PORRES CLINIC (Jhonny M Bazan, MD,PA) 1337 E. PALMA VISTA DRIVE, SUITE A
MISSION, TX 78572 CLIA ID# 45D1039555 (COLA)
SANCTION: Cease Testing for Chloride
EFFECTIVE DATE: March 25, 2019
REASON: Unsuccessful PT
STATUS: On 08/29/2019 the lab removed the test from their Test Menu
JEANIE CHIU, DIRECTOR PRECISION LABORATORY SERVICE
4500 HILLCREAST RD SUITE 120
FRISCO, TX 75035 CLIA ID# 45D1048014 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
JAY WOODY, DIRECTOR CASUS HEALTHCARE LLC DBA LEGACY ER 9205 LEGACY DRIVE FRISCO, TX 75034 CLIA ID# 45D1082696 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
MICHAEL SMITH, DIRECTOR KAI MEDICAL LABORATORY
8230 ELMBROOK DR SUITE 200
DALLAS, TX 75247 CLIA ID# 45D2107660 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
Probation
June 19, 2019
Quality and Severity of Deficiencies Is Significant Enough to Question Ability to Sustain Corrections; Corrective Action Fails to Support Implementation and Prevention of Recurrence in One or More Areas of the Laboratory
Lab Withdrew from Accreditation Program on 11/12/2019
Cease Testing for White Blood Cell Differential (WBC Diff)
May 1, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect
Cease Testing for Immunoglobulins IgA June 3,
2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect
JOSEPH GOIN, DIRECTOR CALVARY MEDICAL CLINIC-LIVINGSTON
309 HWY 59 S LOOP
LIVINGSTON, TX 77351 CLIA ID# 45D2107847 (COLA)
SANCTION: Cease Testing for White Blood Cell Differential (WBC Diff)
EFFECTIVE DATE: January 21, 2019
REASON: Unsuccessful PT
STATUS: No Longer Accredited by COLA
ERICA SWEGLER, DIRECTOR BEACON FAMILY HEALTH CARE
4208 MEDICAL PARKWAY
AUSTIN, TX 78756 CLIA ID# 45D2109658 (COLA)
SANCTION: Cease Testing for White Blood Cell Count (Leukocyte Count) (WBC)
EFFECTIVE DATE: September 4, 2019
REASON: Unsuccessful PT
STATUS: No Longer Accredited by COLA
PEDRO PIEDRA, DIRECTOR
ALKEK CENTER FOR METAGENOMICS & MICROBIOME
RESEARCH/BCM (Baylor College of Medicine) ONE BAYLOR PLAZA BCM MS 385 RM 808E HOUSTON, TX 77030 CLIA ID# 45D2111954 (CAP)
SANCTION: Probation
EFFECTIVE DATE: February 27, 2019
REASON: Quality and Severity of Deficiencies Is Significant Enough to Question Ability to Sustain Corrections; Corrective Action Fails to Support Implementation and Prevention of Recurrence in One or More Areas of the Laboratory
STATUS: Removed from Probation on 08/28/2019
NATALIYA BULAYEVA, DIRECTOR CONCORD LIFE SCIENCES LLC 5151 MITCHELLDALE ST SUITE B10
HOUSTON, TX 77092 CLIA ID# 45D2115019 (CAP)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
FREDERICK NORA, DIRECTOR ER AT SHERMAN, A SERVICE OF TEXOMA MEDICAL CENTER
4226 US HIGHWAY 75 NORTH SHERMAN, TX 75090 CLIA ID# 45D2121775 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
JACQUELINE MONHEIT, DIRECTOR CHI ST LUKE'S HEALTH EMERGENCY CENTER 5161 E SAM HOUSTON PKWY S PASADENA, TX 77505 CLIA ID# 45D2123238 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
Cease Testing for T3 (Triiodothyronine)
July 2, 2019
Unsuccessful PT
Allowed to Resume Testing on 07/16/2019
Cease Testing for PO2
July 29, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect
Cease Testing for White Blood Cell Count (Leukocyte Count) (WBC)
September 20, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect
NOORANISSA PASHA, DIRECTOR BIO CHOICE LABORATORY INC 7505 FANNIN STREET, SUITE 333 CORPUS CHRISTI, TX 78404 CLIA ID# 45D2135859 (COLA)
SANCTION:
EFFECTIVE DATE:
REASON:
STATUS:
PETER CASSON, DIRECTOR
Cease Testing for Chloride
November 5, 2019
Unsuccessful PT
As of 12/31/2019 Cease Testing Still in Effect
NORTHEASTERN REPRODUCTIVE MEDICINE LABORATORIES
105 WEST VIEW ROAD SUITE 302
COLCHESTER, VT 05446
CLIA ID# 47D2079212 (CAP)
SANCTION: Probation
EFFECTIVE DATE: August 28, 2019
REASON: Quality and Severity of Deficiencies Is Significant Enough to Question Ability to Sustain Corrections; Corrective Action Fails to Support Implementation and Prevention of Recurrence in One or More Areas of the Laboratory
STATUS: As of 02/07/2020 Probation Still in Effect
JOHN SUMMERVILLE, DIRECTOR SOUTHSIDE REGIONAL MEDICAL CENTER DBA BON SECOURS MERCY HEALTH PETERSBURG LLC
200 MEDICAL PARK BOULEVARD PETERSBURG, VA 23805 CLIA ID# 49D0230764 (TJC)
SANCTION: Cease Testing Tobramycin
EFFECTIVE DATE: August 23, 2019
REASON: Unsuccessful PT
STATUS: As of 12/31/2019 Cease Testing still in effect
MARY TAYLOR, DIRECTOR ROANE GENERAL HOSPITAL
200 HOSPITAL DRIVE SPENCER, WV 25276 CLIA ID# 51D0234035 (COLA)
SANCTION: Cease Testing for PO2
EFFECTIVE DATE: August 21, 2019
REASON: Unsuccessful PT
STATUS: As of 12/31/2019 Cease Testing Still in Effect
GERALD WEDEMEYER, DIRECTOR UNITED HOSPITAL CENTER LABORATORY
327 MEDICAL PARK DRIVE
BRIDGEPORT, WV 26330 CLIA ID# 51D0236391 (CAP)
SANCTION: Cease Testing for Carbamazepine
EFFECTIVE DATE: July 19, 2019
REASON: Unsuccessful PT
STATUS: Allowed to Resume Testing on 08/02/2019
EDGAR BETANCOURT, DIRECTOR BLOOD CENTER OF NORTHCENTRAL WISCONSIN
211 FOREST ST WAUSAU, WI 54403 CLIA ID# 52D0395282 (AABB)
SANCTION: Cease Testing for Bacterial Contamination
EFFECTIVE DATE: July 1, 2019
REASON: Unsuccessful PT
STATUS: Accepted corrective action; cease testing still in effect until the documentation of the second successful PT event for this analyte is received. As of 12/31/2019 Cease Testing Still in Effect
6. ALL APPEALS AND HEARING DECISIONS. FOR DETAILED INFORMATION REGARDING THE FOLLOWING LISTING SEE CLIA HEARING DECISION INDEX AT HTTP://WWW.CMS.GOV/CLIA/HEARINGGROUP.ASP
KENSINGTON DIAGNOSTICS LLC 15D1019268
DECISION NUMBER: CR5385 DECISION DATE: 8/5/2019 DECISION: FOR CMS
MEDICOS PARA LA FAMILIA 44D0964458
DECISION NUMBER: CR5400 DECISION DATE: 8/21/2019 DECISION: FOR CMS
7. A LIST OF LABORATORIES AGAINST WHICH CMS HAS BROUGHT SUIT UNDER SECTION 493.1846 AND THE REASON FOR THOSE ACTIONS.
*** N O D A T A F O U N D ***
8. A LIST OF LABORATORIES THAT HAVE BEEN EXCLUDED FROM PARTICIPATION IN MEDICARE OR MEDICAID AND THE REASON FOR EXCLUSION.
*** N O D A T A F O U N D ***
9. CORRECTION OF ANY ERRONEOUS STATEMENTS OF INFORMATION THAT APPEARED IN THE 2018 REGISTRY.
*** N O D A T A F O U N D ***